Could I have a recalibration frequency of +/- 15 days ?

We do calibration of measuring instruments as per defined frequency. If the frequency is one year & XXX instrument is calibrated on 1st January 2014, due date of calibration is 30th December 2015.

Due to large quantity of gauges (3000+), we have given tolerance for due date as +/- 15 days. There is written work instruction for this & was being accepted by external ISO auditors from 1993 to 2012.

Now it is not being accepted by external ISO auditors for last 2 years.

External ISO auditors say that it should be calibrated on or before due date of calibration.
My questions are:
1. Is this ok per ISO 9001 standard, as we have documented the practice?
2. What is best practice to follow in case of large volume of gauges?
3. What is the practical solution in this case?
4. Is the external ISO auditors stand correct?
5. How to convince/challenge them?

The same case is also for internal audit frequency. External ISO auditors say that for internal audit should be done on or before earlier date of audit.

Will experts guide please?

Kedarg6500

Good day Kedarg6500,

I have clients who label instruments as "Due October 2014" with the deadline at the end of the month. Nothing stops then from calibrating at any time of the month. Entering this scheme into the procedure means declaring it as process. While I would prefer an actual due date, I have accepted this method and focused my attention on more urgent matters, such as failure to review certificates to determine as-found condition, or failure to assess affected product when an instrument is returned with a failed as-is condition.

Kedarg6500,

As Jennifer suggested you could define "Next Calibration Due" in month and year format, say Dec 2014 instead of mentioning the exact date and this could be defined in your procedure.

But remember that the calibration records and calibration label should mention the actual date of calibration like

Calibration Performed : Dec 4, 2013.
Next Calivbration Due : Dec 2014

Why are some "auditors" a PIA? You would think they would focus on substantive issues. I see no issue with +/- 15 days. As long as you are in your stated timeframe, what difference does it make. What a stupid "finding." We got dinged for "due dates" several years ago. We went to a month/year method. So all gages are calibrated in June 2014. We usually start June 1 and do a few a day until June 30. Good luck.

I don't know why any auditor would be telling you that the system that you have established wouldn't be OK.

Can they cite a reason for it? Is it just their opinion?

Calibration intervals can be established a number of different ways; but whatever method you establish, it should be effective in identifying when instruments should be verified/adjusted before they go out of tolerance.

As far as a +/- interval, well... anyone who is against using that, has never had to manage a calibration program. There are simply too many variables including locating the instrument, scheduling with production, getting the appropriate documentation from an external vendor in and getting it reviewed, etc.

My opinion is to keep the program exactly as you have it, if it works for you and your process. I would query the auditor a little deeper to find out why they consider it unacceptable.

Ask your auditor to point out in the standard where they find that requirement. As long as you have a process (that makes sense) and are following it the auditor can't dictate.

I used the month/year approach and wrote in a +30 with no minimum and never got more than a raised eyebrow. I'll be the first to admit it was not an ideal situation, but nothing we had under calibration was really critical so it worked in that situation. The point is the auditors never hassled me about it.

To reinforce what others have said, I've always done calibrations by month, not day. If something is calibrated in March of 2014 and it's on an annual schedule, the next calibration is due in March of 2015, regardless of the actual date when the 2014 calibration was done.

This tends to be less messy than ? x days. Nonethless, there is nothing in the standard that should prevent you from doing that.

kedarg6500 said:

External ISO auditors say that it should be calibrated on or before due date of calibration.

Click to expand...

Based on what standard? Are they citing ISO 9001, or some other calibration standard in their finding?

kedarg6500 said:

My questions are:
1. Is this ok per ISO 9001 standard, as we have documented the practice?

Click to expand...

ISO 9001:2008 only requires that you maintain records of calibration and verification of your monitoring and measuring equipment. Nowhere in that standard does it tell you how to do those things.

kedarg6500 said:

2. What is best practice to follow in case of large volume of gauges?

Click to expand...

As noted by others here, a general Month/Year is a widely accepted practice.

kedarg6500 said:

3. What is the practical solution in this case?

Click to expand...

See #2.

kedarg6500 said:

4. Is the external ISO auditors stand correct?

Click to expand...

I don't believe it is, based on the information in your post.

kedarg6500 said:

5. How to convince/challenge them?

Click to expand...

Don't think of it as a challenge to the auditor. You won't get good results that way. Just ask them to show you what clause you violated. If you're still unhappy with their answer, you can always appeal the finding.

from all above answers for calibration frequency, can i say the same logic to be applied for internal audit frequency.

any comments

Kedar

Kedar...
You have great responses...
However when the due date is known right through the calender year, nothing must stop you from planning for the calibration (or audit) and executing it per plan. Your plan can build in the required cushion to take care of any logistics issue.
A +/- days looks more like a machining tolerance ..